Recon: RFK Jr. will reportedly require placebo-controlled studies for new vaccines; WHO to support use of weight-loss drugs worldwide
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- RFK Jr. will order placebo testing for new vaccines, alarming health experts (Washington Post) (CNN)
- US FDA Commissioner’s Office Plans Involvement In Many Approvals In Potential Major Change (Pink Sheet)
- FDA to rehire fired staffers who booked inspection trips, but other workers remain in limbo (AP)
- Collins and fellow GOP senators speak out in opposition to Trump’s cuts to biomedical research (STAT)
- Lilly meets sales expectations, but Novo gains on PBM win (Endpoints)
- BeiGene scores a win from US Patent Office in spat over Brukinsa (Endpoints)
- Moderna expands effort to rein in costs in an ‘uncertain environment’ (Endpoints)
- Moderna says FDA has been constructive, but delays flu/COVID shot (Reuters)
- Exits continue at FDA, as more staff in drug office follow fired colleagues out the door (Endpoints)
- US drugmakers increasingly look abroad for clinical trials as confidence in FDA wavers (Endpoints)
- Exclusive: WHO to back use of weight-loss drugs for adults globally, raises cost issue (Reuters)
- Global health funding faces 'greatest disruption' in memory, says WHO director (Reuters)
- Canada’s HTA Agency Reveals How To Submit AI-Driven Evidence (Pink Sheet)
- UK Mandates Unmodified Standardized Contracts To Speed Clinical Trial Set-Up (Pink Sheet)
- Novo Nordisk strikes telehealth deals for obesity drug, following Eli Lilly (STAT)
- Eli Lilly downplays CVS move to drop Zepbound coverage, shares plunge (Reuters)
- M&A is back, but nothing in biotech is neat or simple (STAT)
- Biogen says Leqembi sales are improving slowly following lackluster launch (Endpoints)
- Exclusive: Ex-Calico scientist launches Stately Bio with new way to study cells (Endpoints)
- Arvinas ends plans for two Phase 3 breast cancer trials; Phathom makes cuts (Endpoints)
- After hunt for alternatives, Kronos Bio selects Tang Capital's Concentra for a deal (Endpoints)
- Amicus grabs Dimerix’s rare kidney disease drug for $30M upfront (Endpoints)
- Biogen's results beat estimates on strength in rare disease drugs (Reuters)
- Cardinal Health sees up to $300 million tariff hit in fiscal 2026 (Reuters)
- Another Regeneron CRL Prompts Regulatory Operations Questions (Pink Sheet)
- Teladoc buys virtual therapy startup UpLift for $30M (Endpoints)
- Exclusive: Noma Therapy raises $4M for virtual ketamine-assisted therapy (Endpoints)
- Baxter tops quarterly estimates on strong demand for medical devices (Reuters)
- Medical device maker Becton Dickinson cuts 2025 profit forecast on potential tariff hit (Reuters)
- Nestlé changes how it reports nutritional value of food after criticism (Food Dive)
- FDA Suspends Milk Quality Testing Amid Health and Human Services Cuts (Food Safety)
- Trump administration banned chosen names at FDA, CDC, NIH under new gender policy (USA Today)
- CVS Health’s Aetna to abandon Affordable Care Act insurance marketplaces, again (STAT)
- RFK Jr.’s synthetic dye bans miss a much bigger problem (STAT)
- Why NIH’s policy on grants to universities with DEI programs is not cause for widespread alarm (STAT)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
